DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K102865
• Device Name: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2010-11-03 ( 34 days)
• Product Code: ITX IYN IYO
• Regulation Number: 892.1570

Intended Use

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

Device Description

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

Predicate Devices

K101041, K091941, K102991

Reference Devices

K101041, K091941, K102991

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The description focuses on standard ultrasound imaging modes and safety evaluations.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended uses are for various "exams" to acquire and display ultrasound images for diagnosis, not for treatment.

Diagnostic

Yes
The product's name, "DC-3/DC-3T diagnostic ultrasound system," and the "Intended Use / Indications for Use" section explicitly state its diagnostic purpose. It is used to acquire and display ultrasound images across various medical specialties.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components necessary for acquiring ultrasound images. The performance studies also mention evaluations related to hardware aspects like acoustic output, biocompatibility, and electrical/mechanical safety.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The description of this device clearly states it is a diagnostic ultrasound system that acquires and displays ultrasound images.
• The intended use and anatomical sites listed are all related to imaging the internal structures of the body directly. There is no mention of analyzing biological samples.
• The device description focuses on the imaging technology (ultrasound modes, probes, frequencies). This is characteristic of an imaging device, not an IVD.

Therefore, the DC-3/DC-3T Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

Product codes

IYN, IYO, ITX

Device Description

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc.), neonatal cephalic, transcranial, cardiac, transrectal, peripheral vascular, intraoperative, urology, orthopedics, musculoskeletal (conventional and superficial), Fetal, Intraoperative (Neuro), Laparoscopic, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intravascular

Indicated Patient Age Range

adults, pregnant women, pediatric patients, neonates

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical Tests: DC-3/DC-3T Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3.IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 ,ISO 10993-1 and IEC 62304.

Key Metrics

Not Found

Predicate Device(s)

K101041, K091941, K102991

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

NOV -

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building. Keji 12th Road South, Hi-tech Industrial Park, Nanshan. Shenzhen, 518057. P. R. China

Tel: [phone] Fax: [phone]

Contact Person:

Zhai Pei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: September 27, 2010

2. Device Name:

DC-7 Diagnostic Ultrasound System DC-3/DC-3T Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower

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mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

4. Intended Use:

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

5. Comparison with Predicate Device:

DC-3/DC-3T Diagnostic Ultrasound System is comparable with and substantially equivalent to the Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991) Diagnostic Ultrasound System. They have the same technological characteristics. are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

6. Non-clinical Tests:

DC-3/DC-3T Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3.IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 ,ISO 10993-1 and IEC 62304.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-3/DC-37 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

NOV - 3 2010

Re: K102865

Trade/Device Name: DC-3/DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: September 30, 2010 Received: September 30, 2010

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the DC-3/DC-3T Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5A	6C2	7L5
6CV1	6LE7	7LT4
7L4A	6LB7	D6-2
7L6	3C1
10L4	2P2

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours,

Signature

David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::			510(k) Number (if known):				:			・・	中文	: 湖	ಿಗಳು ಸಾಮಾನ
							Device Name: DC-3/DC-3T Diagnostic Ultrasound System
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Dlagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Dingnostie Ultrasound System nia

Transcucer: Intendod Use;

Sustern:

Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
General
(Track 1 Only)	Specific
(Track 1 & 3)
Ophthalmic	Ophthalmic	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
Fetal
Imaging
& Other	Fetal	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Intraoperative (specify)*	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Small organ(specify)**	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,3,5,6
	Trans-rectal	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Trans-vaginal	P	P	P	P	P	P	P	Note 2,3,5,6
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
Conventional	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Musculo-skeletal
Superficial	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Other (specify)

new indication; Papreviously cizared by FDA; E=added under Appendix E

Addisonal comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + P.W +B.

• ·Intraoperative includes abdominal, theracic, and vascular etc.
• • Small organ-breast, thyroid, testes, etc.
• ** *Other use includes Urology. Note I: Tizsue Harmonie Imaging.
• Note 2; SmarlJD
• Note 3: iScape
• Noter: iBeam
• Notes: Biopsy Quidar

Notes: Frec Xros M

Note?: 4D

STOK

Prescription USE (Per 2

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0030

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Diagnostic Ultrasound Indications for Use Form

System: Transduccr:

DC-3/DC-3T Diagnostic Ultrasound System 3C5A

Intended Use:

Diagnostic altrasound imaging or fluid flow analysis of the turnan body as follows:

	Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Abdominal	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
	Small organ(specify)**
Fetal
Imaging
& Other.	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 1,2,3,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Other (specify)

Additional compens: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Pow

• Intraoperative includes abdominal, thorneie, sod vascular etc.

** Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note I: Tissue Harmonic Imaging,

રાજ્યન

Note 2: Smart3D

Note 3: Scape

Note4: iBeam Notes: Blopsy Guidance -

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices of In Vitro Diagnostic Device Evaluation and Safety

7

Mindray Co. Lt.

System : Transducer:

ndray Co. Ltd. - DC-3/DC-37 Diagnostic Ultrasound Sy

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System ୧୯୬ ।

Diagnostic uttensound Imaging or thaid flow analysis of the human body as follows: Intended Use: : - : : Clinical Application Mode of Operation General Specific Color Amplitude Combined (Track I B ਮ PWD CWD Other (specify) Doppler (Track 1 & 3) Doppler (specify) Only) Ophibalmic Opathalmic Nore2. 3,5,5 િત્તમાં ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ ું નવ P મુજ P P P Abdominal Introperative (specify)" Intraoperative (Neuro) :55 Leparoscopic Pediatric Small organ(specify) ** Neonaral Cephalic Fetal Imaging Adult Cephalic & Other Trans-rectal P P ・ト P P ಕ್ಕಿ Note2, 3,5,6 Trans-vaginal P P P P p ﻬﺎ Note2, 3,5,6 Trans-cretheal Trans-esoph (non-Card.) ... 1 ... Musculo-skeletal Conventional : Musculo-skeletal Superficial futravascular : : Other (specify) *** p P P P P 产 Note 2,3,5,6 Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac 13:40 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Peripheral Vascular ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Peripheral ﺔ ﺍﻟﻤﺘﺤﺪﺓ Vascular Other (specify)

Nenew indication: Pepreviously cleared by FDA: E-added under Appendix E

Additional comments: Combined mades: B+M, PW+B, Calar + B, Power + B, PW +Color+ B, Power + PW +B,

• lotraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

** Small organ-breast, thyroid, testes, exc.

*** Other use includes Urology.

Nate 1: Tissue Harmonic Imaging. Note 2: Smart 3D

Note 3: IScape

Note4: Besm

Notes: Blogsy Guldance

Note6: Free Xros M

Hote7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K K102865

8

Diagnostic Ultrasound Indications for Use Form

System: DC-3/DC-3T Diagnostic Ultrasound System 7L4A Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 1. 1. 11.11.10.2 ... Clinical Application Mode of Operation General Spécific Color Amplitude Combined (Track I B PWD CWD Other (specify) ಹ (Track 1 & 3) Doppler Doppler (specify) Only) Ophthalmic - Ophthalmic Ophihalmic Fetal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abdominal P p P Note 2,3,4,5,6 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic . Pediatric P P P Note 2,3,4,5,6 P P P Small organ(specify) ** P a . P . P P Note 2,3,4,5,6 Fetal Neonatal Cephalic) Ne p P P p Note 2,3,4,5,6 P Imaging Adult Cephalic ...... & Other Trans-rectal . Frans-vaginal Trans-urethral Trans csoph (non-Card.) Musculo-skeletal Conventional p P Note 2,3,4,5,6 P P p - -P Musculo-skeletal Superficial P P P P P p | | || Note 2,3,4,5,6 Intravascular ....... Other (specify) *** Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-Cardiac Cardiac Section . : 发出 Peripheral Peripheral Vascular P P p P : Note 2,3,4,5,6 12 Vascular Other (specify)

Nanew indication; Pepreviously cleared by FDA; E-added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B,

*Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Noted: IBeam

Notes: Biopsy Guidance

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K102865

0033

9

71:6

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer. Intended Use:

Diagnostic ultrasound imaging or finid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**	P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 2,3,4,5,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
	Other (specify)

18 12 12 12 12 12 12 12 12

*Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, lestes, etc.

*** Qther use includes Urology.

Note I: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Note7: 4D'

રાજ્યન

Prescription USE (Per 21 CFR 801 109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0034

10

Diagnostic Ultrasound Indications for Use Form

IOLA

• System: Transducer:
  Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3).		B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**		P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic		P	P	P		P	P	P	Note 2,3,4,5,6
Fetal
Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional		P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial		P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular		P	P	P		P	P	P	Note 2,3,4,5,6
Vascular	Other (specify)

under Appendix E A cleared of the C.

Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW+B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc. ** · Other use includes Urology.

610H

ther than anhydrous C(ClO4)4.

Note 1: Tissue Harmonic Imaging. Note 2: Smart3D

• Note 3: iScape
• -Note4: iBeam

NoteS: Biopsy Guidance

Nate6: Free Xros M

• Note7: 4D
  Presenption USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

DC-3/DC-3T Disgnostic Ultrasound System

11

6C2

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer; Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows;

Clinical Application		Mode of Operation							Other (specify)
General
(Track I Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 2, 3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 2, 3,5,6
	Small organ(specify)**
	Neonatal Cephalic	P	P	P		P	P	P	Note 2, 3,5,6
	Adult Cephalic	P	P	P		P	P	P	Note 2, 3,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2, 3,5,6
Cardiac	Cardiac Adult	P	P	P		P	P	P	Note 2, 3,5,6
	Cardiac Pediatric	P	P	P		P	P	P	Note 2, 3,5,6
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

Nenew indication; Pepreviously cleared by FDA; E=added under Appendix E

Addlikanal comments: Combined modes: 8+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B

• Intraoperative includes stidominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc. *** Other use includes Urology.
• Note 1: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: IBeam
• Notes: Biopsy Guidance Noteb: Free Xros M
• Note7: 4D

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Dieggaesia Dai

Office of In Vitro Diagnostic Device Evaluation and Safety

iption USE (Per 21 CFR 801.109

12

DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

.

System: Transducer: DC-3/DC-3T Diagnostic Ultrasound System 6LE7

Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

Clinical Application	Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal	P	P	P		P	P	P	Note 2,3,4,5,6
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 2,3,4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2,3,4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

Nenew indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

• Small organ-breast, thyroid, testes, etc.

***Other use includes Urology. Note 1; Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note7: 4D

Note5: Biopsy Guidance

Note6: Free Xros M

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102865

(Division Sign-Off)
Division of Radiological Devices

Prescription USE (Per 21 CFR

13

3-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diegnostic Ultrasound System

• System: Transducer:
  Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: : :

1. 2 .. 1 :

&&&

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 2,3,4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2,3,4,5,6
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

Additional comments: Combined modes: B+M, PW+B, Color +B, Power + B, PW +Color+ B, Power +

• Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, lestes, etc.
• *** Other use includes Urology.

Note I: Tissue Harmonic Imaging,

• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam Note5, Biopsy Guidan Note6: Free Xros M Note7: 4D

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102865

14

DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

stem: ransducer Intended Use: DC-3/DC-3T Diagnostic Ultrasound System

3Ci Diagnostic ultrasound imaging or fluid flow analysis of the human body as foll

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combine
d
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
	Small organ (specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P		P	P	P	Note 1,2,3,5,6
	Cardiac Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

dditional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

·Intraoperative includes abdominal, thoracie, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc.
• ***Other use includes Urology,
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam Note5: Biopsy Guidane
• Note6: Free Xros M
• Note7: 4D

(Division Slan-Off) on of Redictorical Devices Diagnostic Device Evaluation and Safety office of In

15

Ltd. - DC-3/DC-3T Diagnostic Ultrasound System indrav Co.

DC-3/DC-3T Diagnostic Ultrasound System System 2P2 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: : Clinical Application Mode of Operation Specific General Color Amplitudé Combined B CWD િ PWD Other (specify) (Track I Only) (Track I & 3) Doppler Doppier (specify) Ophihalmic Ophthalmic Feial Abdominal ﻴﺔ P P P ﻠﻘﺔ P b Note 1, 2,5,6 Intraoperative (specify)* ... ... ... SESS OF Intraoperative (Neuro) 的一个 ... Laparoscopic Scopic Laparato ਸੁਲਮ ( Pediatric . . . P P P b P P b Note 1, 2,5,6 + Small organ(specify) ** Note 1, 2,5,6 Neonatal Cephalic P P P P P P P Fetel Imaging Adult Cephalic P P P P P P Note 1, 2,5,6 P & Other Trans-rectal : Trans-vaginal Trans-urethral Trans-esoph, (non-Card.) 11 Musculo-skeletal Conventional -----Musculo-skeletal Superficial Intravascular . . . . . . . . . . . . . . . Other (specify)*** Cardiac Adult P P P P P Note 1, 2,5,6 P P Cardiac Pediatric b ార్ల b મુજ b P P Note 1, 2,5,6 Cardiac Intravascular (Cardiae) an mas Trans-esoph (Cardiac) :" Intra-Cardiac : : : : : Peripheral Vascular erioheral . Va Other (specify) ...... :

Diagnostic Ultrasound Indications for Use Form

Nenew indication; Pepreviously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, PW: +Color+ B, PW: +Color+ B, Power + PW+B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

• Small organ-breast, thyroid, testes, etc.
• ** Other use includes Urology.
• Note i: Tissue Harmonic Imaging.
• Note 2: Smart BD
• Note 3: iScape
• Note4: iBesm
• Notes : Biopsy Guidance Nate6: Free Xros M
• Nate7: 4D

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102865

16

DC-3/DC-3T Diagnostic Ultrasound System indray Co. Ltd. -

Diagnostic Ultrasound Indications for Use Form

System: Transducer: DC-3/DC-3T Diagnostic Ultrasound System 7LS ...

Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

	Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**	P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 2,3,4,5,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Calor + B, Power + PW +B.

• . Intraoperative includes abdominal, thoracic, and vascular etc.
• ** Small organ-breast, thyroid, testes, etc. . ***Other use includes Urology.
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam
• Note5: Biopsy Guidance
• Note6: Free Kros M
• Note7: 4D

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102865

17

DC-3/DC-3T Diagnostic Ultrasound indray Co.

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System 7LT4

Transducer: Intended Use.

System:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	8	હત	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other Ispecif
Ophthalmic	Ophthalmic Open		ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ	11 11 22 22					presente of
	Fetal Fill
2020 8:52 2017 20:			. Sash .
	Abdominal	P	ﺮ ﺍﻟﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	1 8		ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	P	P	Note 2,3,4,5,6
	Intraoperative {specify)*	P	P	P		p	P	p	Note 2,3,4,5,6
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric :: :	P	P	P		P	P	12	Note 2,3,4,5,6
	Small organ(specify)**	a	. P	P		p	.	P	Note 2,3,4,5,6
Feul	Neonatal Cephalic	P	ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ	P		P	a parti		Note 2,3,4,5,6
Imaging
& Other	Adult Cephalic		11:22:1	ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
	Trans-rectal Section
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	- P	P		P	. 2	P	Note 2,3,4,5,6
	Intravascular
	Other (specify) ***						: 2018年1		1 3 3 3 3 1 1 8 - 2 3 1 1 3
	Cardiac Adult	P P BE		P			and police	. . P	Note 2,3,4,5,6
	Cardiac Pediatric	P		a p		P	P		Note 2,3,4,5,6
Cardinc	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-Cardiac
Peripheril	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
Vascular	Other (specify)

N=new indication; Pepreviously cleared by FDA: Ewadded under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color + B, PW +Color+ B, Po

· Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc.
• ***Other use includes Urology.
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape Note4: iBeam
• Note5: Biopsy Guidance Note6: Free Xros M
• Note7: 4D

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K102865

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18

D6-2

Diagnostic Ultrasound Indications for Use Form

System:

DC-3/DC-3T Diagnostic Ultrasound System

• Transducer: latended Use:
  Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic Ophthalmic
Fetal
Imaging
& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Abdominal	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

: 上一篇: 上一篇: ditional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW

*Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thytoid, testes, etc.
  *** Other use includes Urology.

Note I: Tissue Harmonic Imaging.

• Note 2: Smart3D
  Note 3: iScape

Noted: iBeam Note5 : Blopsy Guidance

Note6: Free Xros M

Note 7: 4D

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510K K102865